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시장보고서
상품코드
1727074
임상시험용 AI 시장 - 인사이트, 경쟁 구도, 시장 예측(2032년)Artificial Intelligence (AI) in Clinical Trials - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
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세계의 임상시험용 AI 시장은 제품별(소프트웨어 및 서비스), 기술별(머신러닝(ML), 자연언어처리(NLP), 기타), 용도별(임상시험 설계 및 최적화, 환자 특정 및 모집, 임상시험시설 특정 및 시험 모니터링, 기타), 치료영역별(종양학, 순환기학, 신경학, 감염증학, 면역학, 기타), 최종사용자별(제약기업 및 바이오테크놀러지기업, 의료기기기업), 지역별(북미, 유럽, 아시아태평양, 기타 지역)은 만성질환 유병률 상승, 제약 및 의료기기기업 간 연구협력 및 제휴활동 증가로 2032년까지 안정된 CAGR 예측으로 성장할 전망입니다.
임상시험용 AI 시장 규모는 2024년 13억 5,079만 달러에 달했습니다. 이 시장은 2025년부터 2032년까지 예측 기간 동안 12.04%의 연평균 복합 성장률(CAGR)로 확대되어, 2032년에는 33억 3,447만 달러에 달할 것으로 예측됩니다. 임상시험용 AI 수요는 당뇨병, 심혈관질환, 호흡기질환, 암 등 만성질환의 세계적인 부담 증가를 주된 요인으로 견조한 성장을 보이고 있습니다. 이 급성장은 창약과 개발 과정의 촉진을 목적으로 하는 투자와 자금 조달 증가에도 지지되고 있습니다. 또한 제약, 생명공학, 의료기기 기업 간의 전략적 제휴와 파트너십 동향 증가는 AI를 활용한 임상시험 솔루션의 채용을 가속화하는데 중요한 역할을 하고 있습니다. 이러한 요인을 종합하면 2025년부터 2032년까지 예측기간을 통해 임상시험용 AI 시장의 확대가 촉진될 것으로 예측됩니다.
임상시험용 AI 시장 역학
만성질환의 유병률 상승은 임상시험용 AI 시장의 성장을 가속할 것으로 예측됩니다.
세계보건기구(WHO)의 2024년 데이터에 따르면 동지중해 지역에서는 2022년에 78만8,000명 이상의 암 진단이 기록되었습니다.
British Heart Foundation이 2024년에 발표한 데이터에 의하면, 세계에서 약 6억 4,000만명이 심장 및 순환기계 질환에 걸려 있어, 이 숫자는 향후 수년간 증가할 것으로 예측되고 있습니다.
마찬가지로 세계 당뇨병 부담도 급속히 증가하고 있습니다. 국제 당뇨병 연합은 2023년, 2021년 시점에서 20-79세의 성인이 5억 3,700만명, 2030년에는 6억 4,300만명, 2045년에는 7억 8,300만명으로 증가했습니다.
2022년 미국 천식 및 알레르기 재단에 따르면, 미국에서는 천식은 18세 이상의 성인 2,200만명 이상에 영향을 미치는 중대한 건강 문제였습니다.의 데이터에서 천식의 유병률은 2021년 270만명에서 2022년에는 280만명으로 증가하고 있습니다.
당뇨병, 심장병, 호흡기 질환, 암 등의 만성 질환으로 고통받는 사람의 수가 계속 늘어나고 있는 가운데, 제약회사나 생명공학기업은 이러한 질환을 특히 타겟으로 한 새로운 치료법, 의약품, 치료법을 개발하기 위한 임상시험을 실시하는 것이 늘고 있습니다. 임상시험 데이터를 기존의 통계적 기법보다 훨씬 신속하게 해석하는 데 도움이 됩니다.
세계의 임상시험 수 증가는 임상시험용 AI의 큰 수요를 촉진하고 시장 성장을 뒷받침하고 있습니다. 국제공동치험의 관리가 복잡해지고 있음을 뒷받침하고 있으며, 임상시험용 AI 시장의 확대가 더욱 가속화되고 있습니다.
신약 개발에 대한 자금 제공과 투자 증가는 임상시험용 AI 시장의 성장을 크게 뒷받침하고 있습니다.
이 연구개발 투자의 급증은 산업계 주도의 연구를 촉진하는 것을 목적으로 한 정부의 이니셔티브에 의해 더욱 지원되고 있습니다. 이러한 관민의 투자는 새로운 치료법이나 기술의 개발에 박차를 가하고 있어, 복잡화 및 다양화하는 임상시험을 관리하는 임상시험용 AI 수요가 높아지고 있습니다. 이러한 연구 개발과 혁신에의 주력 증가는
또한 주요 시장 진출 기업은 임상시험의 피지빌리티 스터디 효율을 높이기 위해 인공지능(AI)을 활용하도록 되어 왔습니다. 2024년 6월, TrialX는 AI를 활용한 Clinical Trial Finder 툴을 발표하고 세계에서 58,000건 이상의 유효한 임상시험에 대한 종합적인 정보에 대한 액세스를 간소화하도록 설계했습니다.
이와 같이 임상시험용 AI 시장은 앞서 언급한 요인이 상호작용하여 2025년부터 2032년까지의 예측기간 동안 큰 성장을 기록할 것으로 예측됩니다.
이러한 유망한 성장 요인에도 불구하고 임상시험용 AI 시장은 과제에 직면하고 있습니다.
임상시험용 AI 시장 부문 분석 :
임상시험용 AI 시장 : 제품별(소프트웨어 및 서비스), 기술별(머신러닝(ML), 자연언어처리(NLP), 기타), 용도별(임상시험 설계 및 최적화, 환자 특정 및 모집, 임상시험시설 특정 및 시험 모니터링, 기타), 치료 영역별(종양학, 심장병학, 신경학, 감염증학, 면역학, 기타), 최종 사용자별(제약 및 바이오테크놀러지 기업, 의료기기 기업), 지역별(북미, 유럽, 아시아태평양, 기타 지역)
임상시험용 AI 시장 제품부문에서는 소프트웨어 카테고리가 2024년에 큰 수익 점유율을 기록할 것으로 예측되고 있습니다. 예를 들어, 유럽 제약 단체 연합회(EFPIA)의 데이터(2024년)에 따르면, 유럽 경제 영역(EEA)에서는 연간 약 4,000건의 임상시험이 승인되고 있습니다.
마찬가지로 WHO(2024년)는 2022년 동남아시아에서 1만966건의 임상시험이 실시되었으며, 2023년에는 1만 1,030건으로 증가한다고 보고하고 있습니다.
임상시험용 AI 소프트웨어는 시험 프로토콜 개발 및 최적화, 적절한 시험 설계 선택, 더 나은 데이터 관리 및 시험 프로토콜, 환자 인구 정의, 시험 목표 달성을 위한 전략 수립에 중요한 역할을 합니다. 프로세스를 합리화하고, 스폰서와 연구자들이 핵심적인 활동에 집중할 수 있게 함과 동시에, 임상시험의 실시를 가속화 합니다.
임상시험 수요 증가에 대응하기 위해, 시장의 주요 기업은 시험의 효율화와 최적화, 환자 모집의 강화, 임상시험 의사 시설에서의 임상시험 설계의 개선을 목적으로 한 혁신적인 AI 툴의 개발을 진행하고 있습니다. 인공지능은 임상시험 개발을 간소화하고 시간, 비용 및 위험을 크게 줄이는 동시에 혁신적인 치료에 대한 환자 액세스를 가속화합니다.
게다가 ConcertAI는 2023년 4월 CTO 2.0을 발표했습니다. CTO 2.0은 또한 후원자가 FDA가 요구하는 종합적인 임상시험의 성과를 달성할 수 있도록 지원하며, 지역 기반의 임상시험과 보다 효율적이고 환자 친화적인 디자인으로의 전환을 지원합니다.
이러한 요인들로부터, 소프트웨어 카테고리는 예측 기간 동안 견조한 성장이 예상되고 임상시험용 AI 시장 전체의 확대를 견인합니다.
북미가 임상시험용 AI 시장 전체를 독점할 것으로 예측됩니다.
북미는 2024년에 임상시험용 AI시장에서 가장 큰 점유율을 차지할 것으로 예측되고 있습니다. 파트너십의 추세가 높아짐에 따라 AI 솔루션의 개발과 함께 시장 개척을 촉진하고 있습니다.
GLOBOCAN의 데이터(2024년)에 따르면, 미국에서 2022년 암 환자 수는 238만189명으로, 2030년에는 279만1,752명으로 증가할 것으로 예측되고 있습니다. 암 환자는 204만 1,910명이 될 것으로 예측됩니다.
게다가 CDC(2024년)는 2022년 미국에서 새롭게 HIV에 감염된 환자는 추정 3만1800명이었다고 보고했습니다. 유망한 후보자와 임상시험 참가자의 식별을 가속화하여 감염증 치료제의 임상시험을 간소화하기 위해 만성질환과 감염증 부담 증가는 AI 주도형 임상시험 수요를 더욱 촉진할 것으로 예측됩니다.
미국 심장협회(2024년)에 따르면 약 970만명의 성인이 진단되지 않은 당뇨병과 공존하고 있습니다만, 2,930만명이 진단되고 있습니다. AI는 질병 진행, 병존 질환 및 라이프 스타일을 기반으로 환자를 클러스터링하고 개입을 조정하고 CGM 데이터와 임상시험 데이터를 통합하여 실시간 인사이트를 얻고 있습니다.
CDC가 발표한 기사(2024년)에 따르면 2022년에는 미국에서 약 620만명의 성인이 심부전으로 고통을 겪고 있다고 진단되었습니다. AI는 심전도, 유전체 데이터, 환자 이력을 분석하여 심부전 및 기타 심혈관 질환의 위험이 높은 사람을 확인함으로써 심혈관 질환의 임상시험에 혁명을 가져오고 있습니다.
게다가 북미의 주요 업계 각사는 임상시험을 가속화하는 고도의 AI 기반 툴을 도입하기 위해 연구개발에 많은 투자를 실시했습니다. 2022년 10월, Phesi는 실시간 시나리오 모니터링을 통해 임상 시험 계획을 최적화하도록 설계된 AI를 활용한 Trial Accelerator(TM) 플랫폼을 발표했습니다. 세계에서 가장 역동적인 임상시험 데이터베이스를 활용한 이 SaaS 솔루션을 통해 임상 개발 팀은 임상시험 결과를 시뮬레이션하고, 환자 모집, 엔드포인트 선택, 국가별 전략, 임상 책임 의사의 시설 배치를 최적화하고, 궁극적으로 임상시험의 효율성과 성공을 높일 수 있습니다.
마찬가지로 H1은 2023년 10월 임상시험의 인텔리전스를 강화하기 위해 Trial Landscape 플랫폼에 통합된 General AI Tool인 GenosAI(TM)의 출시를 발표했습니다.
그러므로 임상시험용 AI 시장에서 위의 모든 요인들은 2025년부터 2032년까지의 예측기간 동안 큰 성장을 기록할 것으로 예측됩니다.
임상시험용 AI 시장의 주요 기업:
임상시험용 AI시장에서 사업을 전개하고 있는 주요 시장 진입기업으로는 TEMPUS, NetraMark, ConcertAI, AiCure, Medpace, ICON plc, Charles River Laboratories, Dassault Systemes, Oracle, Certara, Cytel, Phesi, DeepHealth, Unlearn.ai, H1, LLC, Risklick, Lokavant, Research Solutions 등이 있습니다.
임상시험용 AI 시장에서의 최근 개발 활동:
임상시험용 AI 시장 보고서 조사의 주요 요점
이 임상시험용 AI 시장 조사 보고서에서 이익을 얻을 수 있는 대상자
Artificial Intelligence (AI) in Clinical Trials Market by Product (Software and Services), Technology (Machine Learning (ML), Natural Language Processing (NLP), and Others), Application (Clinical Trial Design & Optimization, Patient Identification & Recruitment, Site Identification & Trial Monitoring, and Others), Therapeutic Area (Oncology, Cardiology, Neurology, Infectious Disease, Immunology, and Others), End-User (Pharmaceutical & Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of chronic diseases and increasing research collaboration and partnership activities among pharma and medical device companies.
The Artificial Intelligence (AI) in clinical trials market was valued at USD 1,350.79 million in 2024, growing at a CAGR of 12.04 % during the forecast period from 2025 to 2032 to reach USD 3,334.47 million by 2032. The demand for AI in clinical trials is witnessing robust growth, largely driven by the increasing global burden of chronic diseases such as diabetes, cardiovascular conditions, respiratory disorders, and cancer. This surge is further supported by rising investments and funding aimed at advancing drug discovery and development processes. Moreover, the growing trend of strategic collaborations and partnerships among pharmaceutical, biotechnology, and medical device companies is playing a crucial role in accelerating the adoption of AI-powered clinical trial solutions. Collectively, these factors are expected to propel the expansion of the AI in clinical trials market throughout the forecast period from 2025 to 2032.
Artificial Intelligence (AI) in Clinical Trials Market Dynamics:
The growing prevalence of chronic diseases is expected to drive AI in clinical trial market growth. For instance, according to GLOBOCAN data from 2023, approximately 20 million new cancer cases were reported in 2022, with this number projected to rise to 32.6 million by 2045 around the world.
As per the data from the World Health Organization (WHO) 2024, in the Eastern Mediterranean Region, over 788,000 cancer diagnoses were recorded in 2022. This figure is anticipated to double to approximately 1.57 million cases by 2045.
According to data published by the British Heart Foundation 2024, approximately 640 million people globally were affected by heart and circulatory diseases, with these numbers anticipated to rise in the coming years. The same source notes that around 67 million individuals are diagnosed with heart or circulatory diseases each year.
Similarly, the global diabetes burden is rising rapidly. The International Diabetes Federation reported in 2023 that 537 million adults aged 20-79 were living with diabetes in 2021, a number expected to increase to 643 million by 2030 and 783 million by 2045.
According to the Asthma and Allergy Foundation of America in 2022, in the United States, asthma was a significant health concern affecting over 22 million adults aged 18 and older. Similarly, data from the Australian Bureau of Statistics in December 2023, the prevalence of asthma is increased from 2.7 million people in 2021 to 2.8 million in 2022. In general, females exhibited a higher propensity for asthma compared to males, with a prevalence rate of 12.2% versus 9.4%.
As the number of people suffering from chronic conditions such as diabetes, heart disease, respiratory diseases, and cancer continues to grow, pharmaceutical and biotechnology companies are increasingly conducting clinical trials to develop new treatments, drugs, and therapies specifically targeting these conditions. AI can help interpret vast amounts of trial data much faster than traditional statistical methods. Predictive models can flag inefficacious treatments or predict outcomes for specific patient subgroups. Therefore, the rising prevalence of chronic disease is driving the market growth.
The rising number of clinical trials worldwide is driving significant demand for AI in clinical trial, fueling market growth. According to ClinicalTrials.gov data, by December 2024, approximately 518,210 clinical trials were listed, up from 477,219 in 2023. This increase underscores the growing complexity of managing global trials, necessitating efficient systems for trial administration, patient management, and data collection. As the volume of trials continues to rise, the need for AI-driven clinical trials to streamline these processes becomes more critical, further accelerating the expansion of the AI in clinical trial market.
Increased funding and investment in drug discovery and development are significantly boosting the growth of the AI in clinical trial market. According to the data from the Pharmaceutical Research and Manufacturers of America (PhRMA) in September 2024, global biopharmaceutical R&D investment reached $276 billion in 2022, spread across 4,191 global companies.
This surge in R&D investment is further supported by government initiatives aimed at fostering industry-led research. For example, in August 2024, the UK government allocated EUR 12 million from the Innovate UK Cancer Therapeutics Programme to support the development of life-changing cancer treatments, including therapies for childhood and young adult cancers. Such public and private sector investments are fueling the development of new treatments and technologies, which in turn drives the demand for AI in clinical trial to manage these increasingly complex and diverse trials. This growing focus on R&D and innovation is expected to continue accelerating the market for AI clinical trial.
Additionally, key market players are increasingly leveraging artificial intelligence (AI) to enhance the efficiency of clinical trial feasibility studies. For instance, in June 2024, TrialX launched its AI-powered Clinical Trial Finder tool, designed to simplify access to comprehensive information on over 58,000 active clinical trials worldwide. This advanced tool utilizes cutting-edge AI to translate complex medical and trial-related data into clear, user-friendly language, making clinical research more accessible to a wider audience. Through the platform, patients and caregivers can register as volunteers, receive tailored trial notifications, and engage more effectively in the clinical research process, ultimately supporting greater participation and accelerating trial recruitment.
Thus, the interplay of aforementioned factors the market for the AI in clinical trials is anticipated to register significant growth during the forecast period from 2025 to 2032.
Despite these promising growth factors, the AI in clinical trial market faces challenges. Concerns regarding patient data & privacy and the complexity of AI integration in clinical trials are significant constraints that could potentially hinder market growth during the forecast period.
Artificial Intelligence (AI) in Clinical Trials Market Segment Analysis:
AI in Clinical Trials Market by Product (Software and Services), Technology (Machine Learning (ML), Natural Language Processing (NLP), and Others), Application (Clinical Trial Design & Optimization, Patient Identification & Recruitment, Site Identification & Trial Monitoring, and Others), Therapeutic Area (Oncology, Cardiology, Neurology, Infectious Disease, Immunology, and Others), End-User (Pharmaceutical & Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the product segment of the AI in clinical trials market, the software category is projected to register a significant revenue share in 2024. The growth of the clinical trial software category can be attributed to the increasing number of clinical trials conducted worldwide and rising R&D activities, along with enhanced research collaborations among key players. For example, data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) (2024), revealed that approximately 4,000 trials are authorized annually across the European Economic Area (EEA).
Similarly, WHO (2024) reported 10,966 clinical trials in Southeast Asia in 2022, with this number rising to 11,030 in 2023. This growing volume of clinical trials is driving the demand for AI software and tools in clinical trial, contributing to the overall market growth.
AI software in clinical trial play a crucial role in developing and optimizing trial protocols, selecting appropriate study designs, better data management and study protocol, defining patient populations, and creating strategies to achieve trial objectives. These AI software streamline trial processes by automating administrative tasks, reducing paperwork, and enhancing data collection, allowing sponsors and researchers to focus on core activities and expedite trial execution. AI algorithms can analyze patient data to match eligible participants to trials more efficiently and helps identify patients more likely to stay through the trial, reducing drop-out rates. AI can simulate trial outcomes based on historical data to optimize trial protocols and it enables real-time adjustments to trial parameters for better results.
To address the increasing demands of clinical trials, key players in the market are developing innovative AI tools to enhance trial efficiency and optimization, enhance patient recruitment, and improved clinical trial design at investigator sites. For instance, in January 2025, Risklick launched Protocol AI, the first AI-powered software designed specifically for clinical trials in the medical device industry. Protocol AI streamlines trial development, significantly reducing time, costs, and risk, while accelerating patient access to innovative treatments. This breakthrough technology represents a major advancement in bringing medical devices to market more efficiently and cost-effectively.
Moreover, in April 2023, ConcertAI launched CTO 2.0, a clinical trial optimization solution that leverages publicly available data and partner insights to provide detailed site and physician-level trial information. It offers operational metrics and site profiles to assess trial performance and capabilities. CTO 2.0 also helps sponsors meet FDA mandates for inclusive trial outcomes, supporting the shift toward community-based trials and more efficient, patient-friendly designs.
Given these factors, the software category is expected to witness robust growth during the forecast period, thereby driving the overall expansion of the AI in clinical trials market.
North America is expected to dominate the overall Artificial Intelligence (AI) in Clinical Trials market:
North America is projected to account for the largest share of the AI in clinical trial market in 2024. This dominance can be attributed to several key factors, including the rising prevalence of chronic diseases in the region, significant investments in research and development, and the increasing number of clinical trials being conducted. Additionally, the growing trend of research collaborations and partnerships between pharmaceutical and medical device companies, coupled with the development of advanced AI solutions are fostering the market growth. These factors are fueling demand for AI-driven clinical trial to manage the complexities of trials, ultimately contributing to the growth of the AI in clinical trial market in North America during forecast period from 2025 to 2032.
Data from GLOBOCAN (2024), stated that there were 2,380,189 cancer cases in US in the year 2022, with projections suggesting an increase to 2,791,752 cases by 2030. Data from American Cancer Society (2025), reported that 2,041,910 new cancer cases expected to be diagnosed in 2025 in the US. AI in cancer trials analyzes genomic and imaging data to identify biomarkers and match patients to targeted therapies to assess tumor progression or treatment outcomes, improving trial precision and success rates.
Furthermore, the Centers for Disease Control and Prevention (CDC) (2024), reported that in 2022, there were an estimated 31,800 new cases of HIV infection in the United States. The increasing burden of chronic and infectious disorders is further expected to fuel the demand for AI-driven clinical trials as AI tools accelerates identification of promising candidates and trial participants through data mining thereby streamlining clinical trial conducted in infectious disease drugs.
According to the American Heart Association (2024), approximately 9.7 million adults are living with undiagnosed diabetes, while 29.3 million have been diagnosed. Furthermore, 115.9 million Americans were reported to be dealing with pre-diabetes as of 2021. AI clusters patients based on disease progression, comorbidities, and lifestyle to tailor interventions and integrate CGM data with clinical trial data for real-time insights.
According to an article published by the CDC (2024), approximately 6.2 million adults were suffering from heart failure in the US in 2022. Same sources further stated that around 20.5 million individual were living with coronary heart disease as of 2022. Furthermore, an estimated 6.5 million individuals aged 40 and older were diagnosed with peripheral artery disease (PAD) in the same year. AI is revolutionizing clinical trial in cardiovascular disease by analyzing ECGs, genomic data, and patient histories to identify individuals at high risk for heart failure and other cardiovascular diseases. This data-driven approach enables early intervention and supports the development of advanced therapies.
Moreover, leading industry players in North America are investing heavily in research and development to introduce advanced AI-based tools to accelerate clinical trials. For example, in October 2022, Phesi launched its AI-powered Trial Accelerator(TM) platform, designed to optimize clinical trial planning through real-time scenario modeling. Leveraging the world's largest and most dynamic clinical trial database, this SaaS solution enables clinical development teams to simulate trial outcomes and optimize patient recruitment, endpoint selection, country strategy, and investigator site allocation, ultimately enhancing trial efficiency and success.
Similarly, in October 2023, H1 announced the launch of GenosAI(TM), a generative AI tool integrated into its Trial Landscape platform to enhance clinical trial intelligence. GenosAI empowers pharmaceutical companies to analyze complex datasets, streamline trial-related queries, and accelerate site and principal investigator (PI) selection, enabling faster, more informed clinical trial launches.
Hence, all the above mentioned factors are anticipated to register significant growth during the forecast period from 2025 to 2032 in the AI in clinical trials market.
Artificial Intelligence (AI) in Clinical Trials Market Key Players:
Some of the key market players operating in the AI in Clinical Trials market include TEMPUS, NetraMark, ConcertAI, AiCure, Medpace, Inc., ICON plc, Charles River Laboratories, Dassault Systemes, Oracle, Certara, Cytel Inc., Phesi, DeepHealth, Unlearn.ai, Inc., H1, TrialX, Suvoda LLC, Risklick, Lokavant, Research Solutions, and others.
Recent Developmental Activities in the Artificial Intelligence (AI) in Clinical Trials Market:
Key Takeaways from the Artificial Intelligence (AI) in Clinical Trials Market Report Study
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